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A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01708616
First received: October 15, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This single-center, randomized, double-blind, two-period crossover study will ev aluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidon e in healthy volunteers. Subjects will be randomized to one of 4 treatment seque nces of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of ap proximately 3 weeks between treatment periods. Anticipated time on study is up t

o 12 weeks (from screening through study completion).


Condition Intervention Phase
Healthy Volunteer
Drug: RO5285119
Drug: RO5285119 placebo
Drug: risperidone
Drug: risperidone placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax) [ Time Frame: Pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic markers for risperidone: Prolactin levels [ Time Frame: Pre-dose to 6 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic assessments for risperidone: Level of sedation [ Time Frame: Pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax) [ Time Frame: Day 1 to Day 18 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC) [ Time Frame: Day1 to Day 18 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + risperidone Drug: RO5285119 placebo
multiple doses
Drug: risperidone
single dose
Placebo Comparator: Placebo +placebo Drug: RO5285119 placebo
multiple doses
Drug: risperidone placebo
single dose
Active Comparator: RO5285119 + placebo Drug: RO5285119
multiple doses
Drug: risperidone placebo
single dose
Experimental: RO5285119 + risperidone Drug: RO5285119
multiple doses
Drug: risperidone
single dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Women have to be postmenopausal or surgically sterile
  • Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing

Exclusion Criteria:

  • Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
  • Positive for hepatitis B, hepatitis C or HIV infection
  • History of clinically significant hypersensitivity or allergic reactions
  • Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
  • Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
  • Administration of an investigational drug or device within 3 months prior to first dosing

    • Hypersensitivity to risperidone or any of its excipients
  • Any other known contraindications to risperidone as stated in the SmPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708616

Locations
France
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01708616     History of Changes
Other Study ID Numbers: BP28318, 2012-003231-31
Study First Received: October 15, 2012
Last Updated: November 24, 2014
Health Authority: France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)

Additional relevant MeSH terms:
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014